There are particular tissue repair procedures that require the delivery of therapeutics to a target site in a patient's body. Optimally, these repair procedures are performed in a way to minimize damage caused by the repair procedure itself while maximizing the accuracy of placement of the therapeutic in relation to the damage site. Often these repair sites are difficult to reach within a patient's body or are sites in tissue where any disturbance of the surrounding environment can exacerbate and limit the repair process.
In this light, although repair procedures utilizing biologic therapeutics have become more prominent, delivery procedures have not. For example, stem cell therapies directed at cartilage or bone repair are now being widely researched, and procedures developed to maximize the therapeutics capacity for a particular target tissue. However, placement of the stem cells at the target tissue site is generally taken for granted, relying on direct placement of the cells by a surgeon, injection of the cells into the site using an 18 g or 20 g needle, or intravenous infusion of the cells into the patient (relying on the cells inherent capacity to find the correct environment or sheer numbers to gain a foothold at the site). A particular tissue repair site of interest is utilized herein to further illustrate the concepts discussed above, the intervertebral disc.
Intervertebral disc, or disc herein, lie between and separate each vertebra of the spine. Vertebrae within the spine are referred to as being in the cervical, thoracic, lumbar or sacrum regions. Each vertebra comes together to form the spinal column, or spine, which function is to protect the spinal cord, and support the body and head.
Discs make up approximately one fourth of the spine's length, each disc acting as a cushion or shock absorber to protect the vertebrae and other aspects of the spine and brain during movement.
Discs are generally non-vascular, fibrocartilaginous tissue composed of a nucleus pulposus and an annulus fibrosus. The nucleus pulposus is centrally located in the disc and composed of a mucoprotein gel that resists compression and provides the cushion of the disc. The annulus fibrosus is a series of concentric sheets of collagen fibers that surround and enclose the nucleus pulposus. Since the annulus fibrosus surrounds and thereby encloses the nucleus pulposus, the nucleus pulposus is capable of providing an even distribution of pressure across the disc. The annulus fibrosus also provides a tethering point between the disc itself and endplates of adjacent vertebra. Manipulation of the disc environment, annulus or pulposus, can lead to additional damage and can further limit the capability of the disc to be repaired by a therapeutic.
Back pain often results from disruption of one or more disc in a patient's spine. Disc disruption is typically caused by trauma, inflammation, herniation, and/or instability of adjacent vertebral bodies. Conventional therapies address the severity of the disc injury, while attempting to minimize risk and cost to the patient. Often, non-surgical approaches are utilized to treat disc-involved back pain, for example, rest, therapeutic exercise and medications are often a first-line defense in the treatment of back pain. These non-surgical approaches are targeted at a gradual and progressive improvement in symptoms for a patient.
However, in some circumstances a damaged disc requires surgical intervention to facilitate repair of the damaged tissue. Surgical intervention includes invasive and/or minimally invasive procedures, where the type of procedure depends on the severity of the injury or damage. With regard to minimally invasive procedures, a number of endoscope or endoscope-like devices tailored for use in the spine have been developed. For example, disc repair procedures that utilize an endoscope (or other like instrument) include procedures for chemonucleolysis, laser directed techniques, and mechanical directed techniques.
Recently, procedures have been proposed for utilizing biologic therapies in disc repair procedures. However, little advancement has been made to facilitate these new therapies, especially with regard to the placement of the therapeutics in the damage site. These procedures require delivery of materials into the disc, for example delivery of stem cells into a site within the disc. Little progress has been made in these stem cell or therapeutic delivery techniques.
As such, there is a need in the art for improved therapeutic delivery devices and methods for the delivery of a therapeutic to a site in a patient. The need in the art requires delivery of therapeutics with high accuracy while minimizing disturbance to the environment of the damage. These devices and methods can be used in the treatment of disc, ligaments, labrum and other like sites.
Against this backdrop the present disclosure is provided.